CIALIS- tadalafil tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

Tadalafil (UNII: 742SXX0ICT) (Tadalafil - UNII:742SXX0ICT)

थमां उपलब्ध:

Cardinal Health

INN (इंटरनेशनल नाम):

Tadalafil

रचना:

Tadalafil 5 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

CIALIS® is indicated for the treatment of erectile dysfunction (ED). If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of CIALIS decreases from 4 weeks until 26 weeks, and the incremental benefit of CIALIS beyond 26 weeks is unknown [see Clinical Studies (14.3)] . Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology (12.2)] . CIALIS is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA® ). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)] . Do not use CIALIS in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including CIALIS, may potentiate the hypoten

उत्पाद समीक्षा:

CIALIS (tadalafil) is supplied as follows: Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes: 20 mg tablets debossed with “C 20” Bottles of approx.. 540 tablets NDC 55154-1832-8 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

CIALIS- TADALAFIL TABLET, FILM COATED
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CIALIS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CIALIS.
CIALIS (TADALAFIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Contraindications, Concomitant Guanylate Cyclase (GC) Stimulators
(4.3)
09/2015
INDICATIONS AND USAGE
CIALIS
is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment
of:
•
•
•
If CIALIS is used with finasteride to initiate BPH treatment, such use
is recommended for up to 26 weeks (1.4).
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg (3).
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
®
erectile dysfunction (ED) (1.1)
the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2)
ED and the signs and symptoms of BPH (ED/BPH) (1.3)
_CIALIS for use as needed:_
•
ED: Starting dose: 10 mg as needed prior to sexual activity. Increase
to 20 mg or decrease to 5 mg based upon
efficacy/tolerability. Improves erectile function compared to placebo
up to 36 hours post dose. Not to be taken
more than once per day (2.1).
_CIALIS for once daily use:_
•
•
•
ED: 2.5 mg taken once daily, without regard to timing of sexual
activity. May increase to 5 mg based upon
efficacy and tolerability (2.2).
BPH: 5 mg, taken at approximately the same time every day (2.3)
ED and BPH: 5 mg, taken at approximately the same time every day (2.3,
2.4)
CIALIS may be taken without regard to food (2.5).
Administration of CIALIS to patients using any form of organic nitrate
is contraindicated. CIALIS was shown to
potentiate the hypotensive effect of nitrates (4.1).
History of known serious hypersensitivity reaction to CIALIS or
ADCIRCA (4.2).
®
Administration with guanylate cyclase (GC) stimulators, such as
riociguat (4.3).
Patients should not use CIALIS if sex is inadvisable due to
cardiovascular status (5.1).
U